Testing Costs and Testing Capacity According to the REACH Requirements – Results of a Survey of Independent and Corporate GLP Laboratories in the EU and Switzerland potx

Research Paper Testing Costs and Testing Capacity According to the REACH Requirements – Results of a Survey of Independent and Corporate GLP Laboratories in the EU and Switzerland Manfr

Research Paper

Testing Costs and Testing Capacity According to the REACH Requirements – Results of a Survey of Independent and Corporate GLP Laboratories in the EU and Switzerland

Manfred Fleischer*

* Research Affiliate at the Social Science Research Center Berlin (WZB), Im Uelenbend 3a, 52159 Roetgen-Rott, Germany, Telephone: +492471133531, mf@euregio-research.de

Abstract: This study focuses on the prices for laboratory testing services and testing capacity in nine of

the major European chemicals producing countries The purpose is to bridge the existing gap of a representative study on test prices and the available testing capacity At the core are seventy-six test categories, in particular toxicological and ecotoxicological tests as required by REACH, the EU Chemicals Policy Review The price and capacity information was gathered by a survey of twenty-eight independent and corporate laboratories in the second half of 2004 The survey aimed at finding out minimum, average and maximum estimates of costs/prices and the available average and maximum testing capacities The data exploration has shown a considerable variability in the prices for single tests For reasons of completeness an overview of the testing cost for a registration according to the four work packages of REACH is provided The most difficult issue was the estimation of average and maximum testing capacities Surprisingly the large laboratories supply with 96.5% the vast amount of the total capacity available for testing chemicals in the nine European countries the survey has covered A complete set of tables and figures representing detailed price and capacity information is available upon e-mail request to the author

Introduction

An effective system of chemicals control in the

EU calls for very detailed information Although a

number of surveys is available no representative

and detailed survey on testing cost as required

according to the REACH proposal is at hand

Neither is there a survey on the available testing

capacity in the EU The most recent study on

testing cost was published in August 2004 by

BAuA the Notification Unit according to the

Chemicals Act at the Federal Institute for

Occupational Safety and Health in Germany [1]

Their survey is based on the requirements for the

notification of new chemical substances The

notification of new chemical substances in the EU

requires specific test data to be provided by the

notifier of the new substance The testing

requirements depend on the volume of the

substance marketed per annum The EU

regulation distinguished three main categories, that

is the “Base Set” of information, “Level 1” data,

and “Level 2” data [2] BAuA has tried to

determine the testing cost for these three

categories However, it does not cover the

complete set of test as required by the REACH

proposal, which can be seen in appendix 1 A

current overview of studies on testing costs is

provided in a study of the German Federal

Environmental Agency [3]

This study is to bridge the gap of a

representative study on test prices and the

available testing capacity The study seeks to

establish a statistical basis for a standard price for

the single tests as specified in the REACH

proposal by exploring the existing price variability

For the testing laboratories offering their services

to a broader market, it is the net price charged to

their customers And, for the company labs, the

standard price is a market-oriented transfer price,

which they would charge to their internal and

external customers Thus, this price comprises

more than the actual or standard costs of a test It

includes all costs associated with the carrying out

of a test, including rent, overhead, and centrally

funded costs, as well as a profit margin Thus, this

price is a good indicator of the single market price

for corporate laboratory services

This study covers the tests as specified by the

European Commission in their REACH proposal

Appendix IV to VIII, dated 29 October 2003 [4]

In several cases the original REACH testing requirements are not specific Therefore, we consulted a paper by Pedersen et al [5] and experts from the testing laboratories, as well as the current literature [6] This survey focuses on 28 laboratories and chemical companies in Austria, Belgium, Denmark, France, Germany, Italy, the Netherlands, Switzerland and the UK

In the next section of the article we briefly discuss a few methodological issues and describe the design of the study The questionnaire and the sampling procedure is described in detail In section three the results are presented and discussed We focus on the variability of prices and its causes and the difficulty of quantifying the available testing capacity Section four summarizes the major findings

Method and data

Methodological considerations

We should start with a theoretical remark about market prices The remark is based on microeconomic theory [7] From a microeconomic viewpoint the price in a competitive market is given, as is the capacity The market price is the price at which demand matches supply The market for laboratory testing services can be regarded as a perfectly competitive market since it has many buyers and sellers, so that no single buyer or seller has a significant impact on price In

a perfectly competitive market a single market price will usually prevail In case the market is not perfectly competitive different laboratories might charge different prices for the same test This can happen when one laboratory is trying to win customers from its competitors, or because customers have loyalties to laboratories, in which case these laboratories can charge higher prices than their competitors

Market prices are only revealed as the result of market transactions For our study this implies checking market transactions regarding laboratory-testing services for the past several years This procedural consideration was put aside during the pilot phase of the study because the laboratories could not afford to check for a representative sample of past market transactions in order to derive prices The only way forward was to focus

on the prices they would charge for their testing

services And, it is reasonable to assume that the

prices for specific laboratory tests will be a good

indicator for the market price

Capacity for testing services is a subtle thing

Usually, for most products, long-run supply is

much more price elastic than short-run supply

This because firms face capacity constraints in the

short run and need time for capacity expansion,

for example by building new testing facilities and

hiring qualified staff It could be that short-run

capacity rises if prices rise sharply The available

capacity is based on the cost function of the

specific laboratory for single tests and on the

relationship to the market price Such a cost

function is a relationship itself between the cost of

conducting such tests and the output of a

laboratory An important issue is how the

structural factors of a laboratory affect this

relationship

Estimating the available capacity for testing

services is difficult and one that is pivotal to the

survey Capacity is difficult to quantify for many

reasons Nearly all laboratories – be they

independent or corporate laboratories – provide

services to several industry sectors Thus, only the

total capacity available could be given Estimation

of capacity is further complicated by the large

diversity of studies the laboratories offer

Study design and data collection

The study was designed as a cross-sectional

survey using a questionnaire We focused on the

EU countries with a large share of chemicals

manufacturing volume and on Switzerland because

this allowed the study to cover most of the

independent and corporate laboratories in Europe

Therefore the study could produce representative

results and remain manageable

The questionnaire covered five major areas

The first column of the questionnaire included the

numbering of the Appendix of the REACH

proposal so that the tests were grouped according

to their subject (see appendix 1) Under the

column, “Test guidelines”, the OECD and EC test

guidelines were also quoted Again, it should be

mentioned that REACH is not specific in all cases

The questionnaire included the following sections:

• General questions about the company/laboratory

• Identification of the substance/

Information on manufacture and use of the substance (3 items)

• Physical-chemical tests (16 items)

• Toxicological tests (28 items)

• Ecotoxicological tests (28 items) The survey aimed at finding out minimum, average and maximum estimates of costs/prices, which were based on costs/prices of the past two years Although one might doubt averages, they do reflect a “sensed” underlying distribution Several factors are influencing the distribution Among others these are the properties of the substances to

be tested, unexpected events during the tests, and intermediate results; because they often determine the effort and inputs for single tests; and as such the costs/prices of these That is the exact actual costs/prices could only be given when details on the substance to be tested are known by the laboratory Moreover, the prices for the single tests

do not include costs for dose range finding and for the development of analytical method

The capacity to conduct testing as required by the REACH proposal is available from both the chemical firms and independent testing laboratories The required tests need to be conducted in general according to the Principles of Good Laboratory Practice (GLP) first published

by the OECD in 1982 and revised in 1997 [8]

This meant for our survey that all prices/costs needed to be based on GLP requirements GLP is

a quality system covering the organisational process and the conditions under which non-clinical safety and environmental studies are planned, performed, monitored, recorded, reported and archived

The following nine categories show the areas of expertise in which laboratories might choose to specialise The category numbers correspond to the official GLP numbering of these fields

1 Physical-chemical testing

These tests measure physical and chemical

properties of substances like melting point,

flammability etc

2 Toxicity studies

These studies assume that tests on animals

can be used to evaluate the toxicity effects

on humans Examples are acute toxicity

studies (oral, dermal, inhalation) and

carcinogenicity studies

3 Mutagenicity studies

These are studies to explore the gene

toxicity of substances, for example gene

mutation studies like the Ames test

4 Environmental toxicity studies on aquatic

and terrestrial organisms

Examples are short-term acute toxicity

studies on daphnia

5 Studies on behaviour in water, soil and air;

bioaccumulation and metabolisation

These studies explore whether and how

substances remain in the environment

Examples are biodegradability and

bioaccumulation studies

6 Residue studies

They are mainly applied to pesticides Tests

are made for all types of agricultural crops

(from corn to hops, fruits and vegetables)

as well as long-term soil degradation

studies

7 Studies on effects on mesocosms and

natural ecosystems

These are very specific studies for

pesticides like Pond studies Artificial

ponds are used to test different

concentrations of substances

8 Analytical and clinical chemistry testing

This is a special category to characterize

laboratories which provide only the

analytical part of testing services from

categories 2 to 7 They are dealing mainly

with biological materials

9 Other studies

The compliance monitoring is organised at the national level The responsible national agencies report on the monitoring results to the OECD GLP Office and to the corresponding office at the

EU Commission

The recent lists of GLP laboratories for the year 2003 mention that Germany has 159 laboratories, the UK 128, France and Switzerland

44 each, the Netherlands 36, and Italy 29 These lists include independent labs and corporate labs, which all conduct their testing in compliance with the GLP Principles

We have used the lists of the GLP laboratories with their areas of expertise to define the parent populations to be considered Besides the eight areas of specialization listed above there are certain industry-specific specializations The products and industries the labs are specialized in include chemicals, pharmaceuticals, agrochemicals, food, biocides and environmental legislation Thus we had to select on a case by case basis those laboratories specialized in testing chemicals Based

on our knowledge and the knowledge of experts

we tried to identify all relevant testing capacity for chemicals in the surveyed countries However, the approach remains arbitrary, mainly due to a lack of more detailed information on the sampled population A disadvantage of this procedure is, that it makes no sense to calculate a response rate because of the necessary but judgemental selection procedure

We discussed the issue and the criteria which laboratories to include in the survey with experts,

in particular with the British and German GLP Offices Several laboratories were easily dropped according to their name, which suggested a business other than chemicals testing More important was a systematic screening of the indicated areas of expertise of the GLP laboratories We could exclude the areas 6) residue studies, 7) mesocosms and natural ecosystem, 8) clinical chemistry (applied for the pharmaceutical industry) and 9) other studies We contacted the remaining GLP laboratories by phone and asked whether they would like to participate in the CEFIC survey The result was that 51 laboratories showed their interest in participating in the survey (see table 1) In the end twenty-eight of these laboratories responded, of which we could use twenty-six in our analysis

The prices and capacity we asked for were from

30 June 2004 The author conducted the survey

from August to December 2004 This long survey

period has to do with the interest in including as

many laboratories as possible It also took a lot of

effort for the laboratories to compile the requested

information We should mention that all of the

large independent laboratories from the nine

participating countries are included, with the

exception of one

We should also mention that there are only a

few corporate labs remaining in existence; in fact

we obtained data from only four corporate

laboratories There is an ongoing process – but

seemingly terminated – of phasing-out corporate

laboratories for toxicological and ecotoxicological

testing (and also for physical-chemical testing)

The process could be observed in all the

participating countries, with the result that few

corporate labs remain If we take a representative

sample of seventeen large European firms which

are listed in the global top fifty chemical

companies in 2004 [9] than only four of them still

have their own significant testing facilities

A separate issue is, that the relative number of

participating corporate labs is considerably lower

than that of independent labs This is due to the

fact, that corporate labs are mainly managing

regulatory compliance issues using independent

labs for testing services These corporate labs

belong to large chemical firms which keep nevertheless the GLP status for their labs, but do not provide extensive testing services This was the main reason for them not to participate in our survey

Results and discussion

Summary of data and analytic technique

The data exploration has shown a considerable variability in the prices for single tests Three attempts were made to reduce the price variability

of the sample The attempts were based on the response pattern to the three requested prices The responses show the following pattern of prices given:

• Average price

• Average, minimum and maximum price

• Minimum and maximum price (price range)

• Minimum price The first and the second responses posed no problem for calculating the mean and median of the average price However, the laboratories have sometimes chosen for the same reason a different response pattern In cases of a broad range of prices for a particular test category some preferred

All labs Participating labs All participating labs Country

Independent Labs Corporate Labs Independent Labs Corporate Labs Number Percent

Table 1: Sample of independent and corporate laboratories involved in the survey

to give minimum and maximum prices only

whereas others preferred to give the average price

instead The problem was that about a third of the

respondents gave only the price range or the

minimum price This information would be lost in

a rigid calculation of the mean and median of the

average price since these respondents would not

enter in the estimation of the statistical parameters

Thus, three options were considered to substitute

the missing average price: first to use the minimum

price; second, to use the mean of the minimum

and the maximum price; and third, to use both of

these substitutes

The reasons not to use these substitutions are

the same that underlie the respondents’ behaviour

The main reason is that there is a strong impact on

testing costs related to the characteristics of the

substance to be tested For a number of tests then,

no normal average price can be given In these

cases only a price range is meaningful However,

this depends on the substances a laboratory usually

tests And in effect, as the responses show, for

some labs an average price is still meaningful,

whereas for others only a price range or a minimum price can be determined

We have experimented with all three approaches to substitute for the missing average price In the end, however, we found no less price variability than analysing the original data with a number of average prices missing

Due to the comparatively small sample size and

to reasons of comparability we limited the following presentation and discussion of the single tests to mean and median values

Analysis of prices

An overview of minimum, average and maximum prices:

Appendix 1 offers an overview of the means of the average prices for the single test categories It also shows the number of laboratories that provided data on average prices For the purpose

of comparison we included the costs as surveyed

by BAuA [1]

Min

price Max price Avg price Test categories

Mean Mean Median Mean (%) CV mean to Ratio

median

v 014 - Development of analytical method 4,567 8,333 2,250 5,239 100 2.3

vi 6.8.1 - Assessment of toxicokinetic

v 7.1.1 - Short-term acute toxicity study on

v 7.1.3 - Short-term acute toxicity study on

vii 7.1.6.1 - Fish early-life stage (FELS)

toxicity test 28,717 47,839 21,000 26,254 60 1.3

vi 7.3.1 - Adsorption/desorption sceening

study(HPLC method) 3,521 2,980 2,600 3,878 96 1.5

vii 7.3.2 - Bioconcentration in (one) aquatic

species,preferably fish 43,873 87,082 28,250 40,333 96 1.4

vii 7.4.2 - Effects on soil micro-organisms 10,311 7,513 6,913 11,765 81 1.7

Table 2: Selection of test categories with high price variability

Price variability and its causes:

We have measured price variability using two

statistical parameters the coefficient of variation

and the ratio mean to median prices

The coefficient of variation expresses the

standard deviation as a percentage of the sample

mean This is useful because we are interested in

the size of the variation relative to the size of the

observation Thus, we can compare the variability

of a test price with a mean of 800 Euros to one of

80,000 Euros The standard deviation alone would

not allow for this possibility Furthermore, the

coefficient of variation is fairly easily understood

and it incorporates all the relevant data However,

there is no general standard for an acceptable level

of price variability Thus, we had to fix a

reasonable boundary

The ratio mean to median of a sample of

observations is a crude measure of the amount of

variability (dispersion) in the distribution of the

sample It is commonly used to measure the skew

of a distribution And it is a simple way of

identifying the test categories with the greatest

variability in prices A step-by-step screening has

led to nine test categories with high price

variability Table 2 summarizes the statistical

properties of these tests

The table shows one extreme outlier in the test

category “Assessment of toxicokinetic behaviour

(vi 6.8.1)” Out of the six responding laboratories

four gave a very low price, one lab gave 7-times

the median of the average price and the outlier lab

100-times the median of the average price One

possible reason for the majority of prices around

1,800 Euro might have to do with the actual legal

requirements In the OECD-Guideline 417

respective EU-Guideline B.36 expensive

experimental testing is applied for a production

volume beginning with 100 tonnes per annum

However the REACH proposal has lowered this

boundary to 10 tonnes per annum Thus, the

majority of the labs might not have considered

changes in the REACH testing requirements

The outlier sheds as well light on three factors,

which may have caused the variability of the

prices First, the prices may not reflect identical

test offers, that is the products are not

homogeneous and thus no single market price is

able to prevail This possibility could not be

avoided in our survey because we could not ask for data covering the whole set of 30,000 chemical substances involved Second, there are economic reasons, which include differences in input factors, efficiency of the laboratories, product portfolio and size, etc Third, there is a miscellaneous category of reasons, such as differences in physical locations, that is when geographical differences are likely to lead to structural differences E.g

laboratories which are located in areas heavily concentrated with firms of the chemical industry might have different demands for their testing services than laboratories in less concentrated areas We discuss how these factors might have influenced the established price variability immediately below An example of a test category with high price variability is “the acute toxicity study on daphnia” Figure 1 shows the distribution

of average prices as a histogram This test uses daphnia which are small crustaceans, about 0.2 to

5 mm in length They are used because they exhibit consistent responses to toxins in water

They are simple to be produced in large number

However, there are differences to do this as well as

in the application of the experimental testing design Figure 1 shows these differences and shows a price advantage of the small labs The most obvious reason for price variability is that the properties of the specific test categories as outlined

in our questionnaire were not perceived as unambiguous The test categories left room for interpretation and diversity The nine test categories in Table 2 illustrate that the prices surveyed may include different testing methods and services We have tried to avoid this systematic bias by indicating the respective OECD and EU testing guidelines in the questionnaire

However, the testing guidelines themselves include

a variety of testing options, which have implications on the cost of the overall test to be undertaken for a specific substance

We should now consider the second reason for price variability, which has to do with economic factors Among the few important economic determinants of cost are: size of the laboratory, prices of input factors (labour and materials), rate

of output (i.e., utilization of fixed laboratory personnel and equipment), quality of input factors, size of the testing lots, laboratory technology, and the organization of the laboratory One determinant on which we have information is the

size of the laboratories Our sample size is not

large enough to test for differences in price means

We can, however, take a look at the actual

differences in prices subdivided by size-classes

And a size-class distribution, which divides our

sample well, is if we define “small labs” as having

1 to 100 employees and “large labs” as having

more than 100

We have tested for the difference in the means

of the average price using only the small and large

labs We applied a Mann-Whitney U-test for the

average price of 76 tests In one case (1.3%) no lab

offered the test and in eight cases small labs did

not offer the tests (10.5%) In five cases (6.6%) we

found a significant statistical difference in the

averages prices between small and large labs at a

5%-level of significance However, for the large

majority of test categories, that is for 62 cases

(81.6%) we found no significant statistical

difference at the 5%-level in the in the price

offered by small and large labs

There are three points that we should mention

First, the small labs are not really that small They

average thirty-one employees In comparison, the

large labs average 386 employees (if we exclude one very large lab) The size of the small labs might be related to comparative advantage E.g

the price advantages of the small labs might be due

to advantages of specialization Small labs generally offer a limited package of tests, which might enable them not to incur high fixed-costs Second,

we have no indication that the small labs have responded strategically, that is that they have responded to us with lower prices then they usually would charge Third, the small labs supply

on average only 3.5% of the overall capacity for testing services, for two thirds of the required tests the large labs supply the entire testing capacity

Due to this fact we have not explicitly included the mean values of the small labs into the estimation

of testing costs for work packages according to REACH However, they are implicitly included because we use the mean values for “All labs”, which the small labs have a strong impact on

Estimation of testing costs for work packages:

For reasons of completeness we provide an overview of the testing cost for a registration according to the four work packages of REACH

The estimation used the mean values of the average and maximum prices for the single tests

The test categories are specified in the Appendix V

to VIII of the REACH proposal of October 2003

The estimated test costs can be adjusted for special cases We have added an estimated amount of costs for the development of analytical methods for the single work packages The amounts are 20,000 Euros for 10-100t/y, 40,000 Euros for 100-1000t/y and 50,000 for >1000 t/y It should be mentioned that the cost for the development of analytical method can vary enormously The important point is, that our survey provides a very detailed and reliable source for actual prices for GLP testing services

For our estimation of package prices we used,

so to speak, three scenarios First, the mean value

of average prices of all labs and second, the one for the large labs The former provides the low price level due to the relative low prices of the small labs it includes The third scenario is based

on the mean value of the maximum prices of all labs The reason that in case of work package

“100-1000 t/y” the maximum price is lower than the average price is that both price means include

v 7.1.1 pa Short-term toxicity study on daphnia: avg price

V 7.1.1 – Acute toxicity study on daphnia

Type of lab N Avg price:

Mean in Euros

Figure 1: Analysis of a test category with high

price variability

partly different labs with a different response

pattern

Analysis of capacity

Difficulty in quantifying capacity:

Laboratories which could perform the tests as

specified in the REACH proposal belong to

subgroups of the main group “74.30 Technical

testing” of the European classification of

economic activities, NACE The subgroups are:

• 74.30.1 Engineering control and analysis,

• 74.30.2 Physical testing and analysis and

• 74.30.3 Chemical testing and analysis

However, most of the Statistical Offices of the

European Member States have only recently begun

to collect information on this service sector, and

they provide – if at all – only data for the main

group 74.30

To our knowledge and based on data

downloaded from the Eurostat database in

February 2005 we can conclude that statistical data

on employment, cost, sales and the size

distribution of laboratories since the year 2000 is

only available for Germany and Italy for NACE

74.30 Thus, we cannot use official statistics for

the purposes of our study Furthermore, this data

is too unspecific for estimating the available

capacity for single tests At best it could give a clue

to make a guess about the overall laboratory

capacity in the EU

We have sampled the laboratories for

participation in this survey based on whether they

perform testing according to GLP This basis for

the sampling of the laboratories has led to a quite

representative picture of the overall testing

capacity for industrial chemicals This is because all

of the large laboratories have responded to our questionnaire, except one lab in the UK, which primarily conducts pre-clinical studies for the pharmaceutical industry Nearly all of the medium-sized and small labs – from Belgium, France, Germany, Italy and the Netherlands – which provide testing services for the chemical industry are included

Note that only very few of the labs with GLP status work for the chemical industry We estimate that the share is less than 10% Furthermore, we have included nearly all of the corporate labs As already mentioned there are very few corporate laboratories left The capacity estimation and questions we asked the laboratories were based on the following considerations

Laboratory capacity is the capability to perform tests according to professional standards or guidelines From an economic perspective the capacity of a laboratory for testing chemical substances represents the rate of operation that will yield the minimum average total cost of tests

Capacity in this sense is not fixed, but will vary with changes in the costs of the factors of conducting the tests Capacity can be regarded as being optimal when a situation is achieved at which cost per unit of test is minimized

The estimations of average and maximum testing capacities are still very difficult because they depend on a number of boundary conditions which impact on capacity management It is particularly difficult for large laboratories with high capacity, which provide services to a number of industry sectors Capacity is further complicated by the large diversity of studies they offer

It is important to recognize that the maximum number of test per annum is the total theoretical capacity of a laboratory for each single test/study

1-10 t/y 10-100 t/y 100-1000 t/y >1000 t/y Average price, all labs 56,360 279,838 799,562 1,582,616

Average price, large labs 70,407 292,269 916,340 1,610,910

Maximum price, all labs 81,120 409,602 872,724 1,966,189

Table 3: Summary of the estimated test costs for work packages of REACH Appendix V-VIII (in Euros

per substance)

type considering no other studies in the same

category Hence, the actual number of studies

conducted – that is the average testing capacity –

does not reach the maximum number but depends

on the number of other tests of the same category

and may vary considerably from year to year

Laboratory management might imply

short-term shifting of capacity from one test category to

another or from one department to another;

however, it does not increase capacity itself We

estimate that about one-half of the laboratory

capacity might be shifted during short-term capacity adjustment

For all these reasons, we have asked the labs to consider an estimation of the average and maximum number of tests based on the number

of tests that they are able to conduct per year, as well as the number of tests they conducted in the past one or two years The critical question certainly concerns the average capacity since this knowledge is needed to determine the number of studies the labs could reasonably run

No of REACH appendix and test category No of labs Total avg capacity

viii 7.4.5 - Long-term toxicity testing on soil invertebrates 2 6

viii 7.6 - Long-term or reproductive toxicity to birds: 3 9

vi 6.7.2 - Developmental toxicity study (rabbits), oral gavage 3 12

vii 7.2.1.4 - Sediment simulation testing (for substances adsorbing to sediment) 6 12

viii 7.4.4 - Long-term toxicity testing on earthworms 7 16

vii 7.3.2 - Bioconcentration in (one) aquatic species, preferably fish 8 19

vi 6.6.1b - Short-term repeated dose tox.: 28 days, inhalation (rats) 8 21

viii 6.6.3 - Long-term repeated dose tox study (longer than 12 month) 10 21

vii 7.4.3 - Short-term toxicity testing on plants 6 25

vi 6.4.2 - In vitro cytogenicity study in mammalian cells (MNT) 3 28

vii 6.7.3 - Two-generation reproduction tox study, oral gavage 11 28

vii 7.2.1.3 - Soil simulation testing (for substances adsorbing to soil) 7 29

viii 7.5 - Long-term toxicity testing on sediment organisms 6 30

Table 5: The 16 test categories with the lowest average annual test capacity in the major European

chemicals producing countries

No of required test packages based on 282

substances p.a

Required test

package

Range of annual volume

in tonne/year

Share of the total number of substances (%) EU capacity (excl an import share of 53%) EU capacity and Switzerland

Table 4: Estimation of the annual overall testing capacity according to the test packages for the

notification of new chemical substances